Administrative Claims Measure for Profiling Hospital Performance Based on 90-Day All-Cause Mortality Following Coronary Artery Bypass Graft Surgery.

BACKGROUND: Coronary artery bypass graft (CABG) surgery is a focus of bundled and alternate payment models that capture outcomes up to 90 days postsurgery. While clinical registry risk models perform well, measures encompassing mortality beyond 30 days do not currently exist. We aimed to develop a risk-adjusted hospital-level 90-day all-cause mortality measure intended for assessing hospital performance in payment models of CABG surgery using administrative data. METHODS: Building upon Centers for Medicare and Medicaid Services hospital-level 30-day all-cause CABG mortality measure specifications, we extended the mortality timeframe to 90 days after surgery and developed a new hierarchical logistic regression model to calculate hospital risk-standardized 90-day all-cause mortality rates for patients hospitalized for isolated CABG. The model was derived from Medicare claims data for a 3-year cohort between July 2014 to June 2017. The data set was randomly split into 50:50 development and validation samples. The model performance was evaluated with C statistics, overfitting indices, and calibration plot. The empirical validity of the measure result at the hospital level was evaluated against the Society of Thoracic Surgeons composite star rating. RESULTS: Among 137 819 CABG procedures performed in 1183 hospitals, the unadjusted mortality rate within 30 and 90 days were 3.1% and 4.7%, respectively. The final model included 27 variables. Hospital-level 90-day risk-standardized mortality rates ranged between 2.04% and 11.26%, with a median of 4.67%. C statistics in the development and validation samples were 0.766 and 0.772, respectively. We identified a strong positive correlation between 30- and 90-day risk-standardized mortality rates, with a regression slope of 1.09. Risk-standardized mortality rates also showed a stepwise trend of lower 90-day mortality with higher Society of Thoracic Surgeons composite star ratings. CONCLUSIONS: We present a measure of hospital-level 90-day risk-standardized mortality rates following isolated CABG. This measure complements Centers for Medicare and Medicaid Services' existing 30-day CABG mortality measure by providing greater insight into the postacute recovery period. It offers a balancing measure to ensure efforts to reduce costs associated with CABG recovery and rehabilitation do not result in unintended consequences.

Quality of informed consent documents among US. hospitals: a cross-sectional study.

OBJECTIVE: To determine whether informed consent for surgical procedures performed in US hospitals meet a minimum standard of quality, we developed and tested a quality measure of informed consent documents. DESIGN: Retrospective observational study of informed consent documents. SETTING: 25 US hospitals, diverse in size and geographical region. COHORT: Among Medicare fee-for-service patients undergoing elective procedures in participating hospitals, we assessed the informed consent documents associated with these procedures. We aimed to review 100 qualifying procedures per hospital; the selected sample was representative of the procedure types performed at each hospital. PRIMARY OUTCOME: The outcome was hospital quality of informed consent documents, assessed by two independent raters using an eight-item instrument previously developed for this measure and scored on a scale of 0-20, with 20 representing the highest quality. The outcome was reported as the mean hospital document score and the proportion of documents meeting a quality threshold of 10. Reliability of the hospital score was determined based on subsets of randomly selected documents; face validity was assessed using stakeholder feedback. RESULTS: Among 2480 informed consent documents from 25 hospitals, mean hospital scores ranged from 0.6 (95% CI 0.3 to 0.9) to 10.8 (95% CI 10.0 to 11.6). Most hospitals had at least one document score at least 10 out of 20 points, but only two hospitals had >50% of their documents score above a 10-point threshold. The Spearman correlation of the measures score was 0.92. Stakeholders reported that the measure was important, though some felt it did not go far enough to assess informed consent quality. CONCLUSION: All hospitals performed poorly on a measure of informed consent document quality, though there was some variation across hospitals. Measuring the quality of hospital's informed consent documents can serve as a first step in driving attention to gaps in quality.

Home Health Care After Skilled Nursing Facility Discharge Following Heart Failure Hospitalization.

BACKGROUND/OBJECTIVE: Heart failure (HF) readmission rates have plateaued despite scrutiny of hospital discharge practices. Many HF patients are discharged to skilled nursing facility (SNF) after hospitalization before returning home. Home healthcare (HHC) services received during the additional transition from SNF to home may affect readmission risk. Here, we examined whether receipt of HHC affects readmission risk during the transition from SNF to home following HF hospitalization. DESIGN: Retrospective cohort study. SETTING: Fee-for-service Medicare data, 2012 to 2015. PARTICIPANTS: Beneficiaries, aged 65 years and older, hospitalized with HF who were subsequently discharged to SNF and then discharged home. MEASUREMENTS: The primary outcome was unplanned readmission within 30 days of discharge to home from SNF. We compared time to readmission between those with and without HHC services using a Cox model. RESULTS: Of 67 585 HF hospitalizations discharged to SNFs and subsequently discharged home, 13 257 (19.6%) were discharged with HHC, and 54 328 (80.4%) were discharged without HHC. Patients discharged home from SNFs with HHC had lower 30-day readmission rates than patients discharged without HHC (22.8% vs 24.5%; P < .0001) and a longer time to readmission. In an adjusted model, the hazard for readmission was 0.91 (0.86-0.95) with receipt of HHC. CONCLUSIONS: Recipients of HHC were less likely to be readmitted within 30 days vs those discharged home without HHC. This is unexpected, as patients discharged with HHC likely have more functional impairments. Since patients requiring a SNF stay after hospital discharge may have additional needs, they may particularly benefit from restorative therapy through HHC; however, only approximately 20% received such services. J Am Geriatr Soc 68:96-102, 2019.

Cardiac Resynchronization Defibrillator Therapy for Nonspecific Intraventricular Conduction Delay Versus Right Bundle Branch Block.

BACKGROUND: The benefits of cardiac resynchronization therapy (CRT) in patients with non-left bundle branch block (LBBB) conduction abnormality have not been fully explored. OBJECTIVES: This study sought to evaluate clinical outcomes among Medicare-aged patients with nonspecific intraventricular conduction delay (NICD) versus right bundle branch block (RBBB) in patients eligible for implantation with a CRT with defibrillator (CRT-D). METHODS: Using the National Cardiovascular Data Registry implantable cardioverter-defibrillator (ICD) registry data between 2010 and 2013, the authors compared outcomes in CRT-eligible patients implanted with CRT-D versus ICD-only therapy among patients with NICD and RBBB. Also, among all CRT-D-implanted patients, the authors compared outcomes in those with NICD versus RBBB. Survival curves and multivariable adjusted hazard ratios (HRs) were used to assess outcomes including hospitalization and death. RESULTS: In 11,505 non-LBBB CRT-eligible patients, after multivariable adjustment, among patients with RBBB, CRT-D was not associated with better outcomes, compared with ICD alone, regardless of QRS duration. Among patients with NICD and a QRS ≥150 ms, CRT-D was associated with decreased mortality at 3 years compared with ICD alone (HR: 0.602; 95% confidence interval [CI]: 0.416 to 0.871; p = 0.0071). Among 5,954 CRT-D-implanted patients, after multivariable adjustment NICD compared with RBBB was associated with lower mortality at 3 years in those with a QRS duration of ≥150 ms (HR: 0.757; 95% CI: 0.625 to 0.917; p = 0.0044). CONCLUSIONS: Among non-LBBB CRT-D-eligible patients, CRT-D implantation was associated with better outcomes compared with ICD alone specifically in NICD patients with a QRS duration of ≥150 ms. Careful patient selection should be considered for CRT-D implantation in patients with non-LBBB conduction.

Risk of Readmission After Discharge From Skilled Nursing Facilities Following Heart Failure Hospitalization: A Retrospective Cohort Study.

OBJECTIVE: Discharge to skilled nursing facilities (SNFs) is common in patients with heart failure (HF). It is unknown whether the transition from SNF to home is risky for these patients. Our objective was to study outcomes for the 30 days after discharge from SNF to home among Medicare patients hospitalized with HF who had subsequent SNF stays of 30 days or less. DESIGN: Retrospective cohort study. SETTING AND PARTICIPANTS: All Medicare fee-for-service beneficiaries 65 and older admitted during 2012-2015 with a HF diagnosis discharged to SNF then subsequently discharged home. MEASURES: Patients were followed for 30 days following SNF discharge. We categorized patients by SNF length of stay: 1 to 6 days, 7 to 13 days, and 14 to 30 days. For each group, we modeled time to a composite outcome of unplanned readmission or death after SNF discharge. Our model examined 0-2 days and 3-30 days post-SNF discharge. RESULTS: Our study included 67,585 HF hospitalizations discharged to SNF and subsequently discharged home. Overall, 16,333 (24.2%) SNF discharges to home were readmitted within 30 days of SNF discharge. The hazard rate of the composite outcome for each group was significantly increased on days 0 to 2 after SNF discharge compared to days 3 to 30, as reflected in their hazard rate ratios: for patients with SNF length of stay 1 to 6 days, 4.60 (4.23-5.00); SNF length of stay 7 to 13 days, 2.61 (2.45-2.78); SNF length of stay 14 to 30 days, 1.70 (1.62-1.78). CONCLUSIONS/IMPLICATIONS: The hazard rate of readmission after SNF discharge following HF hospitalization is highest during the first 2 days home. This risk attenuated with longer SNF length of stay. Interventions to improve postdischarge outcomes have primarily focused on hospital discharge. This evidence suggests that interventions to reduce readmissions may be more effective if they also incorporate the SNF-to-home transition.

Outcomes and costs of remote patient monitoring among patients with implanted cardiac defibrillators: An economic model based on the PREDICT RM database.

BACKGROUND: Remote monitoring of implantable cardioverter-defibrillators has been associated with reduced rates of all-cause rehospitalizations and mortality among device recipients, but long-term economic benefits have not been studied. METHODS AND RESULTS: An economic model was developed using the PREDICT RM database comparing outcomes with and without remote monitoring. The database included patients ages 65 to 89 who received a Boston Scientific device from 2006 to 2010. Parametric survival equations were derived for rehospitalization and mortality to predict outcomes over a maximum time horizon of 25 years. The analysis assessed rehospitalization, mortality, and the cost-effectiveness (expressed as the incremental cost per quality-adjusted life year) of remote monitoring versus no remote monitoring. Remote monitoring was associated with reduced mortality; average life expectancy and average quality-adjusted life years increased by 0.77 years and 0.64, respectively (6.85 life years and 5.65 quality-adjusted life years). When expressed per patient-year, remote monitoring patients had fewer subsequent rehospitalizations (by 0.08 per patient-year) and lower hospitalization costs (by $554 per patient year). With longer life expectancies, remote monitoring patients experienced an average of 0.64 additional subsequent rehospitalizations with increased average lifetime hospitalization costs of $2784. Total costs of outpatient and physician claims were higher with remote monitoring ($47 515 vs $42 792), but average per patient-year costs were lower ($6232 vs $6244). The base-case incremental cost-effectiveness ratio was $10 752 per quality-adjusted life year, making remote monitoring high-value care. CONCLUSION: Remote monitoring is a cost-effective approach for the lifetime management of patients with implantable cardioverter-defibrillators.

Admission diagnoses among patients with heart failure: Variation by ACO performance on a measure of risk-standardized acute admission rates.

BACKGROUND: A key quality metric for Accountable Care Organizations (ACOs) is the rate of hospitalization among patients with heart failure (HF). Among this patient population, non-HF-related hospitalizations account for a substantial proportion of admissions. Understanding the types of admissions and the distribution of admission types across ACOs of varying performance may provide important insights for lowering admission rates. METHODS: We examined admission diagnoses among 220 Medicare Shared Savings Program ACOs in 2013. ACOs were stratified into quartiles by their performance on a measure of unplanned risk-standardized acute admission rates (RSAARs) among patients with HF. Using a previously validated algorithm, we categorized admissions by principal discharge diagnosis into: HF, cardiovascular/non-HF, and noncardiovascular. We compared the mean admission rates by admission type as well as the proportion of admission types across RSAAR quartiles (Q1-Q4). RESULTS: Among 220 ACOs caring for 227,356 patients with HF, the median (IQR) RSAARs per 100 person-years ranged from 64.5 (61.7-67.7) in Q1 (best performers) to 94.0 (90.1-99.9) in Q4 (worst performers). The mean admission rates by admission types for ACOs in Q1 compared with Q4 were as follows: HF admissions: 9.8 (2.2) vs 14.6 (2.8) per 100 person years (P < .0001); cardiovascular/non-HF admissions: 11.1 (1.6) vs 15.9 (2.6) per 100 person-years (P < .0001); and noncardiovascular admissions: 42.7 (5.4) vs 69.6 (11.3) per 100 person-years (P < .0001). The proportion of admission due to HF, cardiovascular/non-HF, and noncardiovascular conditions was 15.4%, 17.5%, and 67.1% in Q1 compared with 14.6%, 15.9%, and 69.4% in Q4 (P < .007). CONCLUSIONS: Although ACOs with the best performance on a measure of all-cause admission rates among people with HF tended to have fewer admissions for HF, cardiovascular/non-HF, and noncardiovascular conditions compared with ACOs with the worst performance (highest admission rates), the largest difference in admission rates were for noncardiovascular admission types. Across all ACOs, two-thirds of admissions of patients with HF were for noncardiovascular causes. These findings suggest that comprehensive approaches are needed to reduce the diverse admission types for which HF patients are at risk.

Defining Multiple Chronic Conditions for Quality Measurement.

BACKGROUND/OBJECTIVE: Patients with multiple chronic conditions (MCCs) are a critical but undefined group for quality measurement. We present a generally applicable systematic approach to defining an MCC cohort of Medicare fee-for-service beneficiaries that we developed for a national quality measure, risk-standardized rates of unplanned admissions for Accountable Care Organizations. RESEARCH DESIGN: To define the MCC cohort we: (1) identified potential chronic conditions; (2) set criteria for cohort conditions based on MCC framework and measure concept; (3) applied the criteria informed by empirical analysis, experts, and the public; (4) described "broader" and "narrower" cohorts; and (5) selected final cohort with stakeholder input. SUBJECTS: Subjects were patients with chronic conditions. Participants included 21.8 million Medicare fee-for-service beneficiaries in 2012 aged 65 years and above with ≥1 of 27 Medicare Chronic Condition Warehouse condition(s). RESULTS: In total, 10 chronic conditions were identified based on our criteria; 8 of these 10 were associated with notably increased admission risk when co-occurring. A broader cohort (2+ of the 8 conditions) included 4.9 million beneficiaries (23% of total cohort) with an admission rate of 70 per 100 person-years. It captured 53% of total admissions. The narrower cohort (3+ conditions) had 2.2 million beneficiaries (10%) with 100 admissions per 100 person-years and captured 32% of admissions. Most stakeholders viewed the broader cohort as best aligned with the measure concept. CONCLUSIONS: By systematically narrowing chronic conditions to those most relevant to the outcome and incorporating stakeholder input, we defined an MCC admission measure cohort supported by stakeholders. This approach can be used as a model for other MCC outcome measures.

Use of Cardiac Resynchronization Therapy Among Eligible Patients Receiving an Implantable Cardioverter Defibrillator: Insights From the National Cardiovascular Data Registry Implantable Cardioverter Defibrillator Registry.

Importance: Cardiac resynchronization therapy (CRT) reduces the risk for mortality and heart failure-related events in select patients. Little is known about the use of CRT in combination with an implantable cardioverter defibrillator (ICD) in patients who are eligible for this therapy in clinical practice. Objective: To (1) identify patient, clinician, and hospital characteristics associated with CRT defibrillator (CRT-D) use and (2) determine the extent of hospital-level variation in the use of CRT-D among guideline-eligible patients undergoing ICD placement. Design, Setting, and Participants: Multicenter retrospective cohort from 1428 hospitals participating in the National Cardiovascular Data Registry ICD Registry between April 1, 2010, and June 30, 2014. Adult patients meeting class I or IIa guideline recommendations for CRT at the time of device implantation were included in this study. Main Outcomes and Measures: Implantation of an ICD with or without CRT. Results: A total of 63 506 eligible patients (88.6%) received CRT-D at the time of device implantation. The mean (SD) ages of those in the ICD and CRT-D groups were 67.9 (12.2) years and 68.4 (11.5) years, respectively. In hierarchical multivariable models, black race was independently associated with lower use of CRT-D (odds ratio [OR], 0.77; 95% CI, 0.71-0.83) as was nonprivate insurance (OR, 0.90; 95% CI, 0.85-0.95 for Medicare and OR, 0.73; 95% CI, 0.65-0.82 for Medicaid). Clinician factors associated with greater CRT-D use included clinician implantation volume (OR, 1.01 per 10 additional devices implanted; 95% CI, 1.01-1.01) and electrophysiology training (OR, 3.13 as compared with surgery-boarded clinicians; 95% CI, 2.50-3.85). At the hospital level, the overall median risk-standardized rate of CRT-D use was 79.9% (range, 26.7%-100%; median OR, 2.08; 95% CI, 1.99-2.18). Conclusions and Relevance: In a national cohort of patients eligible for CRT-D at the time of device implantation, nearly 90% received a CRT-D device. However, use of CRT-D differed by race and implanting operator characteristics. After accounting for these factors, the use of CRT-D continued to vary widely by hospital. Addressing disparities and variation in CRT-D use among guideline-eligible patients may improve patient outcomes.

Risk-standardized Acute Admission Rates Among Patients With Diabetes and Heart Failure as a Measure of Quality of Accountable Care Organizations: Rationale, Methods, and Early Results.

BACKGROUND: Population-based measures of admissions among patients with chronic conditions are important quality indicators of Accountable Care Organizations (ACOs), yet there are challenges in developing measures that enable fair comparisons among providers. METHODS: On the basis of consensus standards for outcome measure development and with expert and stakeholder input on methods decisions, we developed and tested 2 models of risk-standardized acute admission rates (RSAARs) for patients with diabetes and heart failure using 2010-2012 Medicare claims data. Model performance was assessed with deviance R; score reliability was tested with intraclass correlation coefficient. We estimated RSAARs for 114 Shared Savings Program ACOs in 2012 and we assigned ACOs to 3 performance categories: no different, worse than, and better than the national rate. RESULTS: The diabetes and heart failure cohorts included 6.5 and 2.6 million Medicare Fee-For-Service beneficiaries aged 65 years and above, respectively. Risk-adjustment variables were age, comorbidities, and condition-specific severity variables, but not socioeconomic status or other contextual factors. We selected hierarchical negative binomial models with the outcome of acute, unplanned hospital admissions per 100 person-years. For the diabetes and heart failure measures, respectively, the models accounted for 22% and 12% of the deviance in outcomes and score reliability was 0.89 and 0.81. For the diabetes measure, 51 (44.7%) ACOs were no different, 45 (39.5%) were better, and 18 (15.8%) were worse than the national rate. The distribution of performance for the heart failure measure was 61 (53.5%), 37 (32.5%), and 16 (14.0%), respectively. CONCLUSION: Measures of RSAARs for patients with diabetes and heart failure meet criteria for scientific soundness and reveal important variation in quality across ACOs.

Comparative Effectiveness of CRT-D Versus Defibrillator Alone in HF Patients With Moderate-to-Severe Chronic Kidney Disease.

BACKGROUND: Patients with moderate-to-severe chronic kidney disease (CKD) are poorly represented in clinical trials of cardiac resynchronization therapy (CRT). OBJECTIVES: This study sought to assess the real-world comparative effectiveness of CRT with defibrillator (CRT-D) versus implantable cardioverter-defibrillator (ICD) alone in CRT-eligible patients with moderate-to-severe CKD. METHODS: We conducted an inverse probability-weighted analysis of 10,946 CRT-eligible patients (ejection fraction <35%, QRS >120 ms, New York Heart Association functional class III/IV) with stage 3 to 5 CKD in the National Cardiovascular Data Registry (NCDR) ICD Registry, comparing outcomes between patients who received CRT-D (n = 9,525) versus ICD only (n = 1,421). Outcomes were obtained via Medicare claims and censored at 3 years. The primary endpoint of heart failure (HF) hospitalization or death and the secondary endpoint of death were assessed with Cox proportional hazards models. HF hospitalization, device explant, and progression to end-stage renal disease were assessed using Fine-Gray models. RESULTS: After risk adjustment, CRT-D use was associated with a reduction in HF hospitalization or death (hazard ratio [HR]: 0.84; 95% confidence interval [CI]: 0.78 to 0.91; p < 0.0001), death (HR: 0.85; 95% CI: 0.77 to 0.93; p < 0.0004), and HF hospitalization alone (subdistribution HR: 0.84; 95% CI: 0.76 to 0.93; p < 0.009). Subgroup analyses suggested that CRT was associated with a reduced risk of HF hospitalization and death across CKD classes. The incidence of in-hospital, short-term, and mid-term device-related complications did not vary across CKD stages. CONCLUSIONS: In a nationally representative population of HF and CRT-eligible patients, use of CRT-D was associated with a significantly lower risk of the composite endpoint of HF hospitalization or death among patients with moderate-to-severe CKD in the setting of acceptable complication rates.

Use of Remote Monitoring Is Associated With Lower Risk of Adverse Outcomes Among Patients With Implanted Cardiac Defibrillators.

BACKGROUND: We examined the association between the use of remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICD) and all-cause mortality and rehospitalization among patients undergoing initial ICD implant. METHODS AND RESULTS: A limited data set was constructed from Boston Scientific ALTITUDE Registry and National Cardiovascular Data Registry ICD Registry between January 2006 and March 2010. Vital status was determined using the Social Security Death Master File. All-cause mortality up to 3 years was compared in patients who used RPM with those who did not use RPM. Time-dependent frailty Cox models quantified the association between RPM use and all-cause mortality. Analyses were repeated in subgroups based on age, sex, race, ICD type, indication, and cardiomyopathy pathogenesis. Similar methodology examined the association between RPM use and all-cause rehospitalization in patients enrolled in Medicare fee-for-service patients ≥65 years. The study cohort (n=37,742, age 67±13, 72% male) had a 3-year mortality of 20.9% (median follow-up 832 days). In multivariable analyses, patients using RPM (n=22,023, 58%) had lower risk of mortality compared with those not using RPM (hazard ratio 0.67, 95% confidence interval 0.64-0.71, P<0.0001). The 3-year all-cause rehospitalization rate in the Medicare population (n=15,254) was 69.3% (median follow-up 922 days). Risk of rehospitalization of patients using RPM (n=9150, 60%) was lower than those not using RPM (hazard ratio 0.82, 95% confidence interval 0.80-0.84, P<0.0001). Findings were consistent across subgroups. CONCLUSIONS: Among patients undergoing initial ICD implant, RPM use is associated with significantly lower risk of adverse outcomes.

Does Age Influence Cardiac Resynchronization Therapy Use and Outcome?

OBJECTIVES: This study sought to describe the use of CRT-D and its association with survival for older patients. BACKGROUND: Many patients who receive cardiac resynchronization therapy with defibrillator (CRT-D) in practice are older than those included in clinical trials. METHODS: We identified patients undergoing ICD implantation in the National Cardiovascular Disease Registry (NCDR) ICD registry from 2006 to 2009, who also met clinical trial criteria for CRT, including left ventricular ejection fraction (LVEF) ≤35%, QRS ≥120 ms, and New York Heart Association (NYHA) functional class III or IV. NCDR registry data were linked to the social security death index to determine the primary outcome of time to death from any cause. We identified 70,854 patients from 1,187 facilities who met prior trial criteria for CRT-D. The mean age of the 58,147 patients receiving CRT-D was 69.4 years with 6.4% of patients age 85 or older. CRT use was 80% or higher among candidates in all age groups. Follow-up was available for 42,285 patients age ≥65 years at 12 months. RESULTS: Receipt of CRT-D was associated with better survival at 1 year (82.1% vs. 77.1%, respectively) and 4 years (54.0% vs. 46.2% , respectively) than in those receiving only an ICD (p < 0.001). The CRT association with improved survival was not different for different age groups (p = 0.86 for interaction). CONCLUSIONS: More than 80% of older patients undergoing ICD implantation who were candidates for a CRT-D received the combined device. Mortality in older patients undergoing ICD implantation was high but was lower for those receiving CRT-D.

Cardiac resynchronization therapy in women versus men: observational comparative effectiveness study from the National Cardiovascular Data Registry.

BACKGROUND: Women have been under-represented in trials of cardiac resynchronization therapy-defibrillators (CRT-D). Previous studies suggest that women benefit from CRT-D at shorter QRS duration than men and that there may be no benefit of CRT-D in patients without left bundle branch block (LBBB) regardless of patient sex. METHODS AND RESULTS: We compared sex-specific death risk in 75 079 patients with New York Heart Association class III or IV heart failure, reduced left ventricular ejection fraction, and prolonged QRS duration (≥120 ms) receiving either CRT-D or implantable cardioverter defibrillator in subgroups according to QRS morphology and 10-ms increments in QRS duration. We applied propensity score weighting to control for differences between treatments. Among patients with LBBB, women receiving CRT-D had a lower relative death risk than those receiving an implantable cardioverter-defibrillator (absolute difference, 11%; hazard ratio=0.74 [95% confidence interval, 0.68-0.81]). In men, the lower mortality with CRT-D versus implantable cardioverter defibrillator was less pronounced (absolute difference, 9%; hazard ratio=0.84 [0.79-0.89]; sex×device interaction P=0.025). In those without LBBB, the mortality difference was modest and did not differ between women and men (absolute difference, 3%; hazard ratio=0.88 [0.79-0.97] in women and absolute difference, 2%; hazard ratio=0.95 [0.91-0.998] in men; interaction P=0.17). In subgroups according to QRS duration, CRT-D was associated with better survival in both sexes with LBBB and QRS ≥130 ms, whereas there was no clear relation between QRS duration and survival in patients without LBBB regardless of patient sex. CONCLUSIONS: In a large real-world population CRT-D was associated with a lower mortality risk in both sexes with LBBB, although more pronounced among women. Only among those with LBBB, both sexes had better survival with longer QRS duration. The mortality differences in patients without LBBB were attenuated in both sexes.

Rates of and factors associated with infection in 200 909 Medicare implantable cardioverter-defibrillator implants: results from the National Cardiovascular Data Registry.

BACKGROUND: The rate of implantable cardioverter-defibrillator (ICD) infections has been increasing faster than that of implantation. We sought to determine the rate and predictors of ICD infection in a large cohort of Medicare patients. METHODS AND RESULTS: Cases submitted to the ICD Registry from 2006 to 2009 were matched to Medicare fee-for-service claims data using indirect patient identifiers. ICD infections occurring within 6 months of hospital discharge after implantation were identified by ICD-9 codes. Logistic regression was used to examine factors associated with risk of ICD infection. Of 200 909 implants, 3390 patients (1.7%) developed an ICD infection. The infection rate was 1.4%, 1.5%, and 2.0% for single, dual, and biventricular ICDs, respectively (P<0.001). Generator replacement had a higher rate compared with initial implant (1.9% versus 1.6%, P<0.001). The factors associated with infection were adverse event during implant requiring reintervention (odds ratio [OR], 2.692; 95% confidence interval [CI], 2.304-3.145), previous valvular surgery (OR, 1.525; 95% CI, 1.375-1.692), reimplantation for device upgrade, malfunction, or manufacturer advisory (OR, 1.354; 95% CI, 1.196-1.533), renal failure on dialysis (OR, 1.342; 95% CI, 1.123-1.604), chronic lung disease (OR, 1.215; 95% CI, 1.125-1.312), cerebrovascular disease (OR, 1.172; 95% CI, 1.076-1.276), and warfarin (OR, 1.155; 95% CI, 1.060-1.257). CONCLUSIONS: Patients who developed an ICD infection were more likely to have had peri-ICD implant complications requiring early reintervention, previous valve surgery, device replacement for reasons other than battery depletion, and increased comorbidity burden. Efforts should be made to carefully consider when to reenter the pocket at any time other than battery replacement.